MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES CUREWRAP; SYSTEM, THERMAL REGULATING

Lot Number M220761

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2022

Event Type  malfunction  

Event Description

Hypothermia blanket found to be leaking and replaced.Patient not affected.Manufacturer response for cooling blanket, curewrap (per site reporter) no response to date.

• Brand Name: CUREWRAP
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston rd.; billerica MA 01821
• MDR Report Key: 15939533
• MDR Text Key: 305068958
• Report Number: 15939533
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: M220761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 DA
• Patient Sex: Female
• Patient Weight: 2 KG